Hologic receives FDA approved for HIV test

Photo | Grant Welker Hologic's Marlborough headquarters

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Hologic has won U.S. Food and Drug Administration approval for an HIV test the Marlborough manufacturer says is the first in the country that can be used for both diagnosis and viral load monitoring.

The test, called Aptima HIV-1 Quant Dx Assay, was first given FDA approval in 2016 for viral load monitoring. The assay, or testing procedure, is part of Hologic's automated Panther diagnostics system. It is also approved by regulators for use in Europe.

FDA approval, which Hologic announced Friday, has the potential to improve patient care because of Aptima's highly sensitive and reliable testing, Hologic's president of diagnostic solutions, Kevin Thornal, said in a statement. A testing program allowing viral load management with diagnosis will allow healthcare providers to guide treatment choices for patients to begin therapy immediately, he said.

Starting treatment at the time of diagnosis is expected to reduce the risk of HIV transmission to others and to maximize prospects for long-term good health, Hologic said.

Approximately 1.2 million people in the U.S. are living with HIV, according to HIV.gov, a website of the U.S. Department of Health & Human Services. About 14% of those don't know they have it. An estimated 36,400 new HIV infections occurred nationally in 2018, according to the latest federal data.